A Pilot Study of Soursop Tea in Patients With Relapsed/Refractory Acute Myeloid Leukemia (AML) or Multiple Myeloma (MM)
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorRoger Strair
About this trial
Purpose/Specific Aims
The study will determine if there is a reduction in malignant cell burden when patients with relapsed and/or refractory acute myeloid leukemia (AML) or multiple myeloma (MM) consume tea made from the dried leaves of Annona muricata (Soursop).
The study goal is to determine the safety and anti-neoplastic efficacy of Annona muricata tea when taken in escalating frequency over a period of 21 days by patients with relapsed/refractory AML or MM for whom there are no standard therapeutic options.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with relapsed or refractory AML or MM not on any anti-neoplastic therapy who have exhausted all therapies and have no available therapy.
For AML: Quantifiable leukemia cells in blood (patients without circulating AML blasts may participate if they agree to baseline and post-treatment bone marrow testing)
For MM: Quantifiable M component (SPEP) or serum free light chain abnormality (ratio greater than 10)
ECOG PS 0,1, or 2
Disqualifiers
Inability to understand the study procedures
Inability to understand the consent form --Pregnancy, breastfeeding, or inability or unwillingness to use effective contraception
Trial design
Design model
Single group
Treatments tested in this trial
Soursop tea
Biological/VaccineThe study is designed to test soursop tea therapy for 21 days, seven at each of 3 dose levels (1, 2 and 3 eight-ounce cups of soursop tea/d with each tea bag containing 1.5g of Shavuot leaves). Some patients may be on study for longer periods due to delays for toxicity observation. Only one delay will be allowed per patient. The patients will be assessed for leukemic or myeloma burden at the end of therapy. All patients will be monitored until resolution of tea-associated toxicities. All patients continuing soursop tea after the 21 days of treatment will continue to be followed for response and toxicity. If a specific intervention-associated CTCAE grade 2 or greater irreversible toxicity occurs in more than one person, the study will be stopped.
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: 10 patients will be enrolled with the diagnosis of relapsed/refractory acute myeloid leukemia (AML)Experimental treatment 1 intervention
Group B: 10 patients will be enrolled with the diagnosis of relapsed/refractory multiple myeloma (MM)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Dependent Variables or Outcome Measures
Reduction in AML cell percentage in blood or bone marrow e.g. (a \>50% reduction in circulating leukemia cells) for the AML cohort. A 50 percent reduction in monoclonal protein or serum free light chains in the multiple myeloma cohort. Tea-associated toxicity will be graded by CTCAE v6 standards.
Time frame
From enrollment until end of treatment- 21 daysOther outcomes
1
Dependent Variables or Outcome Measures
The assessments chosen are greatly simplified because of the pilot nature of the study. 1. AML response will be measured as a percentage change in AML blast count in blood and/or bone marrow at the completion of therapy. 2. Multiple myeloma response will be determined by percentage change in serum M component (when assessable) and/or involved serum free light chain (when assessable).
Time frame
From enrollment until end of treatment- 21 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Roger Strair
Lead sponsor
The Cooper Health System
Sponsor institution
Source ClinicalTrials.gov